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Intensity Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update
First patient dosed in randomized, Phase 2 study in presurgical triple negative breast cancer SHELTON, Conn., Nov. 13, 2024 /PRNewswire/ -- Intensity
About this update from Intensity Therapeutics, Inc.
[{"type":"text","content":"First patient dosed in randomized, Phase 2 study in presurgical triple negative breast cancer\nSHELTON, Conn., Nov. 13, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. (\"Intensity\" or \"the Company\") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, announces third quarter 2024 financial results and provides a corporate update.\n\n \n \n \n \n \n \n\n \nCorporate Update\nINVINCIBLE-3 Study: a Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second and third line treatment for certain soft tissue sarcoma subtypes. The INVINCIBLE-3 Study is expected to enroll 333 patients and initiate sites in eight countries. The primary endpoint in the INVINCIBLE-3 Study is overall survival.\nJuly 2024: the first patients were dosed in the U.S. in the INVINCIBLE-3 Study.July 2024: authorization received from Health Canada to initiate the INVINCIBLE-3 Study in Canada.September 2024: authorization received from The European Medicines Agency to initiate the INVINCIBLE-3 Study in Europe.October 2024: authorization received from Australia's Therapeutic Goods Administration to initiate INVINCIBLE-3 Study in Australia.INVINCIBLE-4 Study: a Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care (\"SOC\") treatment in patients with early-stage, operable triple-negative breast cancer (\"TNBC\") and SOC alone. The primary endpoint is the pathological complete response (\"pCR\") rate in the primary tumor and affected lymph nodes. The INVINCIBLE-4 Study is expected to enroll approximately 54 patients in Switzerland and France.\nSeptember 2024: authorization from the Swiss Medic and the Swiss Ethics Commission to initiate the INVINCIBLE-4 Study.October 2024: first patient dosed in the INVINCIBLE-4 Study.\"This has been an excellent quarter of regulatory success in multiple countries. We received the regulatory authorizations needed to initiate sites in eight countries for our Phase 3 global sarcoma study and our Phase 2 breast cancer study in Switzerland,\" said Lewis H. Bender, Intensity Founder, Presid...